Status:
TERMINATED
A Phase I Study of MK-4827 for Treatment of Solid Tumors (MK-4827-005)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Neoplasms
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will evaluate whether oral administration of MK-4827 to participants with advanced solid tumors is generally safe and well tolerated.
Eligibility Criteria
Inclusion
- Participant must have a histologically or cytologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. There is no limit on the number of prior treatment regimens.
- Participant has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group(ECOG) Performance Scale
- Participant must have adequate organ function (per prespecified laboratory values).
Exclusion
- Participant has had major surgery, chemotherapy, radiotherapy, hormonal or biological therapy within 4 weeks (6 weeks for nitrosoureas, mitomycin C, or bevacizumab) prior to entering the study.
- Participant has known central nervous system metastases or a primary central nervous system tumor.
- Participant is pregnant or breast feeding, or expecting to conceive or father children within the projected duration of the study.
- Participant is known to be Human Immunodeficiency Virus (HIV)-positive.
- Participant with active Hepatitis B or C.
- Participant has symptomatic ascites or pleural effusion.
- Participant has interstitial lung disease as a history or current evidence.
- Participant has known bleeding tendency or coagulation disorder as a history or current evidence, and/or participant is taking any anti-coagulant and/or antiplatelet therapies.
- Participant has uncontrolled persistent or active infection (acute infection which requires antibiotic or anti-fungal treatment).
- Participant has participated in a clinical trial with a known Poly (ADP-ribose) polymerase (PARP) inhibitor.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01226901
Start Date
November 1 2010
End Date
November 1 2011
Last Update
June 28 2012
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